Dynamics of the Immune Response to COVID-19 / Infection by SARS-CoV-2

Completed

• Conditions: SARS-CoV-2; Viral Infection; COVID-19

• Registration Number: NCT04655521
• Lead Sponsor: Universität des Saarlandes

Brief Summary

To evaluate host-immune biomarkers including TRAIL, IP-10, CRP and their computational integration for predicting COVID-19 and disease severity in patients with PCR-confirmed COVID-19.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-02
• Study First Submitted: 2020-12-02
• Study First Submitted QC: 2020-12-04
• Study First Posted: 2020-12-07
• Primary Completion: 2021-06-30
• Study Completion: 2021-09-30
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-23
• Last Update Posted: 2021-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

Inclusion Criteria

• signed informed consent
• confirmed infection with SARS-CoV-2 (except for the controls)

Exclusion Criteria

• n/a

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differential expression of biomarkers between COVID-19 and controls	up to 90 days	Differential expression of TRAIL, IP-10, CRP, and their computational integration in subjects with COVID-19, as compared to control subjects.
Differential expression of biomarkers between severe and non-severe COVID-19	up to 90 days	Differential expression of TRAIL, IP-10, CRP, and their computational integration in subjects with COVID-19, who require more extensive medical intervention (i.e., exhibit severe symptoms), i.e. severe infection vs. non-severe infection
Correlation of biomarkers with disease severity	up to 90 days	Correlation between host-immune biomarkers including TRAIL, IP-10, CRP, and their computational integration for predicting disease severity in patients with COVID-19, where measures of severity include ICU admission, respiratory failure, mechanical ventilation, septic shock, non-respiratory organ failure, and mortality.

Secondary Outcome Measures

Name	Time	Method
Correlation of biomarkers with viral load	up to 90 days	Correlation between host-immune biomarkers including TRAIL, IP-10, CRP, and their computational integration with infectiousness, i.e. e.g. viral load.
Biomarkers depending on therapy	up to 90 days	Differential expression of TRAIL, IP-10, CRP, and their computational integration in subjects with COVID-19 with or without specific therapy.
Biomarkers depending on bacterial co-infection	up to 90 days	Differential expression of TRAIL, IP-10, CRP, and their computational integration in subjects with COVID-19 with or without bacterial co-infection.

Trial Locations

Locations (1)

Saarland University; 🇩🇪 Homburg, Germany